Bristol Myers Squibb: At the Forefront of Immuno-Oncology Research

Renal Cell Carcinoma

Investigational Trials With Bristol Myers Squibb Immuno-Oncology Agents

©2020 Bristol-Myers Squibb Company. All rights reserved. Printed in USA. ONCUS2003384-01-01 10/20

CA209-531/EA8143/NCT03055013Phase 3 Randomized Study Comparing Perioperative Nivolumab vs Observation in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) An independent trial by the ECOG-ACRIN Cancer Research Group with funding from the National Cancer Institute

Study InformationStatus: recruiting Study Phase: 3Estimated Enrollment: 805Estimated Primary Completion Date: November 30, 2023Estimated Study Completion Date: November 30, 2023

Select Key Eligibility Criteria Outcome MeasuresKey inclusion criteria

• TNM staging: ≥ T2Nx or any node-positive RCC; M0 or oligometastatic disease that can be rendered NED

• Planned for nephrectomy • ECOG PS 0–1• ≥ 18 years of age

Key exclusion criteria• Concurrent or prior systemic therapy for RCC• Active or suspected autoimmune disorders (exceptions: vitiligo, diabetes type 1,

psoriasis not requiring systemic treatment, hypothyroidism treated with stable hormone replacement, or conditions not expected to recur)

• Conditions requiring systemic steroids (> 10 mg prednisone or its equivalent daily)• Women must not be pregnant or breastfeeding• Any medical condition that the investigator determines will increase the risk

associated with study participation or interfere with safety results

Primary objective• Event-free survival

Secondary objectives• Overall survival• Recurrence-free survival

among patients with ccRCC• Safety and tolerability

CA209-8Y8/NCT03873402Phase 3b, Randomized, Double-Blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

Study InformationStatus: recruitingStudy Phase: 3bEstimated Enrollment: 418Estimated Primary Completion Date: January 28, 2022Estimated Study Completion Date: January 27, 2025

Study Design

Select Key Eligibility Criteria Outcome MeasuresKey inclusion criteria

• Histological confirmation of ccRCC with or without sarcomatoid features

• Advanced or metastatic RCC, measurable per RECIST v1.1• No prior systemic therapy for RCC• IMDC intermediate or poor risk

Key exclusion criteria• Any active CNS metastases• Active, known, or suspected autoimmune disease• Prior therapy with checkpoint inhibitor

Primary objectives• Progression-free survival

(BICR) • Objective response rate

Secondary objectives• Overall survival• Overall response rate• DCR, DOR, and TTR• Progression-free survival

(investigator assessed)• Safety and tolerability

CA209-914/NCT03138512Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

Study InformationStatus: recruitingStudy Phase: 3Estimated Enrollment: 1600Estimated Primary Completion Date: April 10, 2023Estimated Study Completion Date: July 1, 2024

Study Design

Select Key Eligibility Criteria Outcome MeasuresKey inclusion criteria

• Complete kidney tumor resection 4–12 weeks after randomization

• Meet 1 TNM staging and grading criteriona: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; or pT any, G any, N1 M0

• Postnephrectomy confirmation of predominantly ccRCC with or without sarcomatoid features

Key exclusion criteria• Active known or suspected autoimmune disease

or conditions requiring systemic treatment with corticosteroids

• Prior therapy with checkpoint inhibitor • Known history of positive test for HIV or known AIDS• Severe or serious, acute or chronic medical or psychiatric

condition or laboratory abnormality that may increase any risk associated with study participation

Primary objective• Disease-free survival

(part A and part B)Secondary objectives

• Overall survival (part A and part B)

• Incidence of adverse events (part A and part B)

• Disease-free survival (part B: arm A vs arm C)

a For details and definitions, please refer to American Cancer Society, Kidney Cancer Stages (https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/staging.html). CNS, central nervous system; ccRCC, clear cell renal cell carcinoma; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; G, grade; IMDC, International Metastatic RCC Database Consortium; NED, no evidence of disease; R, randomization; RCC, renal cell carcinoma; RECIST, Response Evaluation Criteria in Solid Tumors; TTR, time to response

This panel represents investigational, unapproved use of the products listed. This is not a complete list of BMS investigational trials. Additional ongoing studies can be found at ClinicalTrials.gov.

Patients with nonmetastatic RCC

Nivolumab Resection Nivolumab

Resection Observation ObservationR

Patients with advanced or metastatic RCC and

intermediate or poorrisk factors

Nivolumab + ipilimumab

Nivolumab + placebo

R

Study Design

Patients withhigh-risk

localized RCCR Resection

PlaceboNivolumab + ipilimumab

Nivolumab + ipilimumabNivolumab + placebo

Placebo

Part A

Part BArm AArm BArm C